Class Class II

Precision AI Surgical Planning System (PAI-SPS) (K251558)

K251558 2026-01-12 Traditional
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Description

Precision AI Surgical Planning System (PAI-SPS) by Precision AI Pty, Ltd., an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251558
Clearance Date2026-01-12
Clearance TypeTraditional
Product CodeQHE
Regulation Number888.3660

Categories

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